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Combination Chemotherapy in Treating Patients With Recurrent Glioblastoma Multiforme



Combination Chemotherapy in Treating Patients With Recurrent Glioblastoma Multiforme

For Condition: recurrent adult brain tumor,adult glioblastoma multiforme
Status: No longer recruiting
Sponsor(s): Atlantic Health System ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating patients who have recurrent glioblastoma multiforme.
Details: OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of temozolomide and carboplatin in patients with recurrent glioblastoma multiforme. II. Determine the acute and long-term toxic effects of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients. IV. Determine the potential of either a pharmacokinetic- or pharmacodynamic-mediated drug interaction in patients treated with this regimen. V. Determine the objective response rate in patients treated with the established MTD of this regimen. VI. Determine time to tumor progression and survival in patients treated with this regimen. PROTOCOL OUTLINE: This is a dose-escalation study. Patients are stratified according to prior nitrosourea-based chemotherapy (yes vs no). Patients receive carboplatin IV over 30 minutes on day 1 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients with a persistent response may continue to receive temozolomide only for an additional 6 courses. Cohorts of 3-6 patients receive escalating doses of carboplatin and temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive carboplatin and temozolomide at the recommended phase II dose. PROJECTED ACCRUAL: A total of 13-70 patients (3-30 for phase I and 10-40 for phase II) will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed recurrent glioblastoma multiforme - Measurable disease --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent sargramostim (GM-CSF) - Chemotherapy: No prior temozolomide; No prior platinum-based chemotherapy - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Recovered from prior major surgery - Other: Recovered from prior therapy; No other concurrent investigational drugs --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 OR Karnofsky 70-100% - Life expectancy: At least 15 weeks - Hematopoietic: Granulocyte count greater than 1,500/mm3; Hemoglobin at least 10.0 g/dL; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT no greater than 3 times ULN - Renal: Creatinine no greater than 1.5 mg/dL - Cardiovascular: No myocardial infarction within the past 6 months; No congestive heart failure requiring therapy - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; HIV negative; No active or uncontrolled infection; No psychiatric disorders that would preclude study; No other severe concurrent disease that would preclude study; No frequent vomiting or other medical condition that would interfere with oral medication administration (e.g., partial bowel obstruction); No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MichaelGruber,  Study Chair,  Atlantic Health System

Overlook Hospital
Summit,  New Jersey,  07902-0220
United States
 


Additional Information:
Study ID Numbers:  CDR0000068432;  NYU-9948,NCI-G00-1907,SPRI-NYU-9948,NCI-V01-1650
Study Start Date: December 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014105

Other Recurrent Adult Brain Tumor Studies:
1. Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor

2. Biological Therapy in Treating Patients With Primary or Advanced Glioma

3. Fenretinide in Treating Patients With Recurrent Malignant Glioma

4. Interferon alfa in Treating Patients With Recurrent Unresectable Meningiomas and Malignant Meningiomas

5. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma

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Combination Chemotherapy in Treating Patients With Recurrent Glioblastoma Multiforme
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